Moderna and merck announce mrna-4157/v940, an investigational personalized mrna cancer vaccine, in combination with keytruda(r) (pembrolizumab), met primary efficacy endpoint in phase 2b keynote-942 trial
Mrna-4157/v940, in combination with keytruda, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to keytruda monotherapy in stage iii/iv melanoma patients with high risk of recurrence following complete resection results are the first demonstration of efficacy for an investigational mrna cancer treatment in a randomized clinical trial companies plan to discuss results with regulatory authorities and initiate a phase 3 study in melanoma in 2023 and rapidly expand to additional tumor types cambridge, ma and rahway, nj / accesswire / december 13, 2022 / moderna, inc. (nasdaq:mrna), a biotechnology company pioneering messenger rna (mrna) therapeutics and vaccines, and merck (nyse:mrk), known as msd outside of the united states and canada, today announced that the phase 2b keynote-942/mrna-4157-p201 trial of mrna-4157/v940, an investigational personalized mrna cancer vaccine, in combination with keytruda®, merck's anti-pd-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (rfs) versus keytruda alone for the adjuvant treatment of patients with stage iii/iv melanoma following complete resection. adjuvant treatment with mrna-4157/v940 in combination with keytruda reduced the risk of recurrence or death by 44% (hr=0.56 [95% ci, 0.31-1.08]; one-sided p-value=0.0266) compared with keytruda alone.
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